Retrospective Chart Review Study Guide and Checklist
Access the NYMC College Forms on our website: http://www.nymc.edu/
Click on Research, Office of Research Administration, Human Subjects Research, human forms.
Download and save as a Word document.
Submission Checklist:
Cover Memo
Complete College forms
Commonly missed items:
College forms, page 1: Complete study conduct time frame fields: from __ to__ and the
facilities section.
Complete the Human Involvement Abstract page.
A Study Protocol (see Appendix 1 for elements of a protocol).
The data collection tool, with all variables to be extracted from chart, should be submitted on a
separate page as either an Excel Sheet or Word Document.
A Waiver of Consent may be requested when direct or indirect subject identifiers will be
recorded. The four Waiver of Consent criteria are located within the College Forms and must be
addressed appropriately on a separate sheet. Do not provide a narrative paragraph; address each
numbered criterion (i.e., 1, 2, 3, 4) separately.
A request for a HIPAA Waiver must be completed and signed. This form is found as a separate
link on the NYMC website under “HIPAA Guide and Forms”.
The NYMC Human Subjects CITI completion report must be submitted in hard copy, for all
research personnel, if not previously provided (see Appendix 2 for details).
The NYMC online financial disclosure form and Conflict of Interest CITI education must be
completed by all research personnel, if not previously done (see Appendix 3 for information).
N.B. The Principal Investigator of the study must have full-time New York Medical College faculty
status.
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Appendix 1
Elements of a Protocol
RESEARCH PLAN
Elements of a Protocol

Face Page - Title, investigators’ names, date (version number and dates if revised)

Specific Aims – What do you intend to accomplish or what is your hypothesis?

Background & Significance - What has been done already?

Methods – How are you going to do the work?

Resources – What resources are available to you?

Evaluation – How will you analyze and interpret data?

References – Relevant literature
If appropriate include:

Description of study population(s)
Number of subjects
Inclusion/exclusion criteria
Breakdown by sex and ethnic categories (if known)

Data collection instrument

Survey or interview instrument (A short introduction should state to subjects that this
is a research project, that subjects do not have to participate, and that subjects do not
have to answer any question that makes them uncomfortable.)
Appendix 2
Educational Program for Those Involved with Human Subjects Research
All persons participating in any research activity involving human subjects are required to complete
the appropriate (Biomedical Research Personnel or Social & Behavioral Research Personnel)
Collaborative Institutional Training Initiative (CITI) course, which is available on-line at:
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www.CITIprogram.org. Failure to meet this requirement will result in delayed permission to initiate
or continue the research study.
Appendix 3
Conflict of Interest Requirements
The College has revised its Conflict of Financial Interest and Code of Conduct Policy; the corresponding
new Annual Disclosure Form for Conflicts of Interest and Commitment can be completed online. The
new form replaces both the existing annual disclosure and the financial conflict of interest
disclosure included in the College forms.
The new College Conflict of Financial Interest Policy requires that:
 investigators disclose significant financial interests annually and within 30 days of discovering
or acquiring a new significant financial interest (investigator means the project director or
principal investigator and any other person, regardless of title or position, who is responsible
for the design, conduct or reporting of research, which may include, for example,
collaborators, research coordinators, postdoctoral fellows, or consultants)
 investigators must complete education regarding these policies by completing the online
Collaborative Institutional Training Initiative (CITI) Conflicts of Interest course (see below).
Please note:
 The annual online Disclosure Form must be completed prior to SUBMISSION of applications.
Only completion of this form will meet the requirement. Updates of the disclosure are
required any time there is a change.
 Prior to initiation of any research project, If ORA determines the existence of a conflict it must
be removed or managed.
 CITI course must be completed prior to EXPENDITURE of grant funds.
To access the Disclosure Form at the NYMC main web site (www.NYMC.edu) :
Click on Offices & Services, at about middle left
Click on InfoTech – ISWeb, in the middle column
Login using your NYMC logon name and password
Click on NYMC Compliance on the left, under NYMC Applications
Click on: Conflict of Interest & Commitment Form
or
Help Using this Form
If required individual(s) can’t access the form, the principal Investigator must send an email request
for Form access to Peter Brown, Associate Vice President at Peter_Brown@NYMC.edu. The request
should include first and last name of each individual, their department, birth date, phone number and
email address. Each individual will receive a response from Information Services indicating the NYMC
login ID and a temporary password.
Questions about the new College Conflict of Financial Interest and Code of Conduct Policy and Annual
Disclosure Form for Conflicts of Interest or Commitment should be directed to the College
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Compliance Officer, at 594-4567 or COIform@NYMC.edu. To access the NYMC policy:
http://www.NYMC.edu/UniversityPolicies/COC_COI.pdf
To access the COI CITI test :
Click on the CITI link: www.CITIprogram.org
If you are registered:
Select Add a Course
Select Conflicts of Interest
If you are not registered:
Follow the registration instructions on the CITI website.
Once you have completed the required modules and received a grade of at least 80% on the related
tests, notification will be sent to the Office of Research Administration.
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